Gene Enlightenment Initiates Phase I/IIa Clinical Trial of GKL-006 Injection for Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Beijing Gene Key Life Technology Co., Ltd. has initiated a Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GKL-006 injection in treating patients with advanced pancreatic cancer. The clinical trial registration number is CTR20252552, and the initial information disclosure date was July 2, 2025.

The drug formulation is an injection, with a specification of 100ml/bag. The dosage is 1 bag per administration, multiple administrations, determined by the actual number of infusions for the subject. The main purpose of this trial is to evaluate the tolerability, safety, and efficacy of GKL-006 injection.

GKL-006 Injection is a biologic product indicated for unresectable locally advanced or metastatic pancreatic cancer. Pancreatic cancer is a malignant tumor that occurs in the pancreas, with inconspicuous early symptoms and possible manifestations of abdominal pain, jaundice, and weight loss in the middle to late stages. Diagnosis relies on imaging and pathological examinations.

The primary endpoint indicators of this trial include the frequency and severity of dose-limiting toxicity (DLT), adverse events (AE), and serious adverse events (SAE); tumor assessment results. Secondary endpoint indicators include tumor assessment results, 1-year OS rate; the frequency and severity of AE and SAE, as well as the incidence of abnormalities in laboratory tests, electrocardiograms, physical examinations, and vital signs.

Currently, the experiment is in progress (not yet recruiting), with a target enrollment of 46 participants.